Kroger Cetirizine Hydrochloride Tablets USP, 10 mg

Manufacturer
Kroger Company | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-09-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:13:32

Label at a glance#

ProductALLERGY
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 10 mg

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS SECTION

Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

OTC - WHEN USING SECTION

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

(1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions
adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over: ask a doctor
children under 6 years of age: ask a doctor
consumers with liver or kidney disease: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Other information

  • store between 20° to 25°C (68°to 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cetirizine-hcl-365s-labelcetirizine-hcl-365s-labelcetirizine-hcl-365s-ifccetirizine-hcl-365s-ifccetirizine-hcl-70s-140s-labelcetirizine-hcl-70s-140s-labelcetirizine-hcl-140s-ifccetirizine-hcl-140s-ifccetirizine-hcl-70s-labelcetirizine-hcl-70s-labelcetirizine-hcl-70s-ifccetirizine-hcl-70s-ifc

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN5
1014678cetirizine hydrochloride 10 MG Oral TabletSCD5
1014678cetirizine HCl 10 MG Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-692-14ALLERGY70 in 1 BOTTLETABLET, FILM COATED705
41226-692-14ALLERGY2 in 1 CARTONTABLET, FILM COATED25
41226-692-65ALLERGY1 in 1 CARTONTABLET, FILM COATED15
41226-692-65ALLERGY365 in 1 BOTTLETABLET, FILM COATED3655
41226-692-70ALLERGY70 in 1 BOTTLETABLET, FILM COATED705
41226-692-70ALLERGY1 in 1 CARTONTABLET, FILM COATED15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41226-69241226-692-65, 41226-692-14, 41226-692-70

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078933-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-06-15
A078933-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-06-15
A078933-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-06-15
A078933-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-06-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15d8e5a09893c0…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLERGYCETIRIZINE HYDROCHLORIDEKroger Companybc020340-ef39-e49a-e053-2a95a90af8102025-09-11WarningsExact identifier
ndc (package): 41226-692-14
ndc (package): 41226-692-70
ndc (package): 41226-692-65
ndc (product): 41226-692
ndc11 (package): 41226069214
ndc11 (package): 41226069270
ndc11 (package): 41226069265
spl id: 3e7fad54-62e1-6d0a-e063-6394a90a5785
spl set id: bc020340-ef39-e49a-e053-2a95a90af810